Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-05 @ 8:50 AM
Study NCT ID:
NCT02939027
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma
Sponsor:
Instituto de Investigacion Sanitaria La Fe
Organization:
Study Overview
Official Title:
Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
Detailed Description:
* Rationale: Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment.
* Objective: To determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
* Study design: Prospective, out-patient based, single centre, single treatment modality
* Study population: 40 patients, \>18 years old, having at least 1 BCC. Intervention: BCC will be treated with EBT, using low-energy X-rays. Area of the lesion will be evaluated for tumour presence and size before, during and at 2 weeks, 6 weeks and 3 months after treatment. If the patient has more than one BCC, all of them will be treated with Electronic Brachytherapy but only the largest one will be analysed in the study.
* Main study parameters/endpoints: Local control of BCC.
* Secondary parameters: Acute skin toxicity, skin cosmesis, and care giver satisfaction, and patient satisfaction.
* Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be exposed to low-energy X-rays. Required site-visits are: 1 pretreatment visits (intake/informed consent and biopsy), 6 treatment visits over the course of 2-3 weeks, 6 control-visits 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
* Patients will also be asked to complete a short questionnaire to evaluate their quality of life.
* Objective: To determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
* Study design: Prospective, out-patient based, single centre, single treatment modality
* Study population: 40 patients, \>18 years old, having at least 1 BCC. Intervention: BCC will be treated with EBT, using low-energy X-rays. Area of the lesion will be evaluated for tumour presence and size before, during and at 2 weeks, 6 weeks and 3 months after treatment. If the patient has more than one BCC, all of them will be treated with Electronic Brachytherapy but only the largest one will be analysed in the study.
* Main study parameters/endpoints: Local control of BCC.
* Secondary parameters: Acute skin toxicity, skin cosmesis, and care giver satisfaction, and patient satisfaction.
* Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be exposed to low-energy X-rays. Required site-visits are: 1 pretreatment visits (intake/informed consent and biopsy), 6 treatment visits over the course of 2-3 weeks, 6 control-visits 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment.
* Patients will also be asked to complete a short questionnaire to evaluate their quality of life.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: